NCT04853303

Brief Summary

Chemotherapy-induced nausea and vomiting, sleep quality and pain are the common symptoms experienced by children with cancer. These symptoms significantly devastate the children's quality of life. Hypnosis is found to be effective in managing chemotherapy-induced nausea and vomiting, sleep quality and pain in children with cancer. In addition, virtual reality is shown to promote the effectiveness of hypnosis in managing these symptoms. However, no study so far has examine it effectiveness in Hong Kong Chinese children with cancer. This study aims to investigate the effectiveness in the use a virtual reality device to improve chemotherapy-induced nausea and vomiting, sleep quality and pain among children with cancer in Hong Kong.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

May 20, 2021

Status Verified

May 1, 2021

Enrollment Period

3.4 years

First QC Date

April 16, 2021

Last Update Submit

May 18, 2021

Conditions

NeoplasmsChildNauseaVomitingSleep HygienePain

Outcome Measures

Primary Outcomes (3)

  • The Pediatric Nausea Assessment Tool (PeNAT) at the 6-month follow-up

    Children will be required o fill in the Chinese version of the Pediatric Nausea Assessment Tool (PeNAT) at 6-month follow-up. The score ranges from 1 to 4. Higher scores represent a more severe nausea.

    at the 6-month follow-up

  • Pittsburgh Sleep Quality Index (PSQI) at the 6-month follow-up

    Children will be required to fill in the Pittsburgh Sleep Quality Index (PSQI) at the 6-month follow-up. The score ranges from 0 to 21. Higher scores represent to poorer sleep quality.

    at the 6-month follow-up

  • Visual Analogue Pain Scale (VAS) at the 6-month follow-up

    Children will be required to fill in the Visual Analogue Pain Scale (VAS) at 6-month follow-up. The score ranges from 0 to 10. Higher scores represent a higher level of pain.

    at the 6-month follow-up

Secondary Outcomes (9)

  • The Pediatric Nausea Assessment Tool (PeNAT) at baseline

    at baseline

  • The Pediatric Nausea Assessment Tool (PeNAT) at 1-month follow-up

    at 1-month follow-up

  • The Pediatric Nausea Assessment Tool (PeNAT) at 3-month follow-up

    at 3-month follow-up

  • Pittsburgh Sleep Quality Index (PSQI) at baseline

    at baseline

  • Pittsburgh Sleep Quality Index (PSQI) at 1-month follow-up

    at 1-month follow-up

  • +4 more secondary outcomes

Study Arms (2)

Hypnosis VR

EXPERIMENTAL

The experimental group will receive a 15-minute hypnosis using virtual reality when they are experiencing chemotherapy-induced nausea and vomiting, sleep quality or pain.

Device: Hypnosis VR

Control

NO INTERVENTION

The control group will receive no intervention.

Interventions

Hypnosis VRDEVICE

Children will be required to wear a VR gadget for hypnosis when they are experiencing chemotherapy-induced nausea and vomiting, sleep quality or pain. The duration is 15 minutes.

Hypnosis VR

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged 9 to 18
  • Can read Chinese and speak Cantonese
  • diagnosed with cancer

You may not qualify if:

  • with mental disabilities or cognitive dysfunction as identified in the medical record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

NeoplasmsNauseaVomitingSleep HygienePain

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsHealth BehaviorBehaviorNeurologic Manifestations

Study Officials

  • Eva Ho, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Ho, PhD

CONTACT

27666417kyanho@polyu.edu.hk

Katherine Lam, PhD

CONTACT

27666420kwkatlam@polyu.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 16, 2021

First Posted

April 21, 2021

Study Start

September 1, 2021

Primary Completion

January 31, 2025

Study Completion

June 30, 2025

Last Updated

May 20, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share